Paroxetine and Interpersonal Psychotherapy for Maintaining Health and Well-being in Elderly Individuals With Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-03-31

Study Completion Date

2005-08-31

Brief Summary

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This study will evaluate the effectiveness of paroxetine versus interpersonal psychotherapy and a combination of the two in helping elderly patients with depression remain well and improve quality of their lives.

Detailed Description

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This is primarily a study of maintenance therapies, not a study of acute therapeutic efficacy, in late-life major depression. The study aims to identify factors that encourage maintenance of treatment gains and to identify which patients need which kinds of treatment to remain well. The following questions are to be addressed:

* Is the probability of recurrence different among the treatment groups?
* What variables may be related to, or predictive of, differences among groups?
* After 1 to 2 years of maintenance therapy, will patients assigned to maintenance combined treatment with both paroxetine and interpersonal psychotherapy remain well at higher rates than patients assigned to paroxetine alone, interpersonal psychotherapy alone, or placebo?
* Will the time to recurrence differ across treatment groups, and what variables may be related to, or predictive of, time to recurrence?

The major study hypothesis is that combined treatment with paroxetine and interpersonal psychotherapy will be superior to either treatment alone (and to placebo) in preventing recurrence of major depressive episodes in patients aged 70 and above.

For information on related studies, please follow these links:

http://clinicaltrials.gov/show/NCT00000377

http://clinicaltrials.gov/show/NCT00177671

Conditions

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Unipolar Depression

Keywords

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Depression Elderly Late Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Interpersonal Psychotherapy

Intervention Type BEHAVIORAL

paroxetine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 69 or older
* meets DSM-IV criteria for current unipolar major depression
* HRSD (17 item) score of 15 or higher
* Folstein Mini Mental Status exam score of 18 or higher

Exclusion Criteria

* Lifetime diagnosis of any psychotic disorder or bipolar disorder
* alcohol or drug abuse within the past six months
* MATTIS Dementia Rating Score of 120 or less
* Contraindication to SSRI therapy
* Hyponatremia

Minimum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Charles F Reynolds III, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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Reynolds CF 3rd, Dew MA, Pollock BG, Mulsant BH, Frank E, Miller MD, Houck PR, Mazumdar S, Butters MA, Stack JA, Schlernitzauer MA, Whyte EM, Gildengers A, Karp J, Lenze E, Szanto K, Bensasi S, Kupfer DJ. Maintenance treatment of major depression in old age. N Engl J Med. 2006 Mar 16;354(11):1130-8. doi: 10.1056/NEJMoa052619.

Reference Type RESULT

PMID: 16540613 (View on PubMed)

Carreira K, Miller MD, Frank E, Houck PR, Morse JQ, Dew MA, Butters' MA, Reynolds CF 3rd. A controlled evaluation of monthly maintenance interpersonal psychotherapy in late-life depression with varying levels of cognitive function. Int J Geriatr Psychiatry. 2008 Nov;23(11):1110-3. doi: 10.1002/gps.2031.

Reference Type DERIVED

PMID: 18457338 (View on PubMed)

Other Identifiers

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971156

Identifier Type: -

Identifier Source: secondary_id

DATR A4-GPS